U.S. Pat. No. 9,125,660 describes an obstruction device (also called pyloric plug) for obstructing or reducing flow through a body lumen, in particular for obstructing or reducing flow of gastric contents across the pyloric valve (pylorus). The device is particularly useful in a transoral gastrointestinal procedure, but may be used in other laparoscopic, endoscopic, or natural orifice procedures in other body lumens. The plug is designed to be fully operative over a long time, and it can be removed and re-implanted.
The plug includes two balloons, one proximal and the other distal, mounted on a shaft. The proximal obstruction balloon is arranged to fit in the stomach, whereas the distal obstruction balloon is arranged to fit in the duodenum. When inflated, both balloons expand towards the pylorus from opposite sides on the pylorus, thus fixing the plug in place.
The plug is particularly useful to stop the flow of stomach contents to the proximal gut which includes the duodenum and the initial part of the jejunum. Such a need arises, for example, after creating an alternative path of flow through a gastro-jejunum anastomosis which bypasses the proximal gut. There could be other cases when this need arises, such as after surgery in the duodenum area or in the pancreas or bile outputs to the duodenum. Another indication could be the need to operate endoscopically on the stomach with an inflated stomach. In this case, the plug keeps the inflating air in the stomach and it does not bloat the intestine.
FIG. 1A illustrates the obstruction device 10 and delivery system 20 of U.S. Pat. No. 9,125,660. Obstruction device 10 includes a proximal obstruction balloon 12 and a distal obstruction balloon 14 mounted on a shaft 16. A portion of shaft 16, referred to as neck 18, provides a gap between proximal balloon 12 and distal balloon 14. Neck 18 can have different lengths and thicknesses depending on the application; for example, the dimensions of neck 18 are correlated to the usual width of the pylorus muscle.
The proximal obstruction balloon 12 is arranged to fit in the stomach, whereas the distal obstruction balloon 14 is arranged to fit in the duodenum. When inflated, balloons 12 and 14 expand towards the pylorus from opposite sides on the pylorus, thus fixing the plug 10 in place.
Distal obstruction balloon 14 may include a plurality of internal or external anchoring arms 19. One purpose of arms 19 is to help anchor the device against the pylorus in the duodenum. Another purpose is to create a non-uniform surface for pushing against tissue (e.g., the distal side of the pylorus). The non-uniform surface may help prevent creating constant pressure against the duodenal side of the pylorus; constant pressure has the disadvantageous risk of causing a sore, like a pressure sore, on the tissue
Delivery system 20 includes an insertion tool 22 (separate from the plug) and an injection site assembly 24 assembled with one of the balloons, preferably, but not necessarily, the proximal balloon 12. Insertion tool 22 includes a shaft 26 that has a hollow lumen 27 for passing therethrough an inflation tube 28 (tube, catheter or syringe and the like). The distal end of shaft 26 is provided with a connector 30, which connects to injection site assembly 24 and which permits passing injection tools, injection fluid and other tools or substances therethrough.
Connector 30 may include a plurality of resilient fingers 32 (made of a suitable resilient, medically safe material, e.g., stainless steel, NITINOL or others) which serve as leaf springs. Injection site assembly 24 includes a proximal insertion port 34 and a distal receiving member 36, the proximal insertion port 34 being smaller in diameter than the distal receiving member 36. Injection site assembly 24 further includes a proximal septum 38, which serves as the proximal injection site 38, and a distal septum 40, which serves as the distal injection site 40, which is axially spaced from the proximal injection site 38. An inflation lumen 42 extends through shaft 16 and is in fluid communication with one or more proximal inflation ports 44 for inflation of proximal balloon 12 and with one or more distal inflation ports 46 for inflation of distal balloon 14.
In FIG. 1B, inflation tube 28 has advanced distally through both proximal injection site 38 and distal injection site 40. Distal balloon 14 is inflated with saline, air or other fluid, from a fluid source (not shown) flowing through distal inflation port 46. In FIG. 1C, inflation tube 28 is withdrawn proximally so that distal septum 40 is now sealed and proximal balloon 12 is inflated with fluid flowing through proximal inflation port 44. Optionally, proximal balloon 12 could be inflated first. Each balloon expands in a required direction so that as it expands, it increases pressure on the pylorus.
Both balloons may be deflated by connecting tube 28 to a source of negative pressure (vacuum) and sequentially introducing tube 28 to each injection site; instead of injecting fluid to the balloon, the balloon is emptied by suction of fluid from the balloon.